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Quantification of HBsAg in nucleos(t)ide-naı¨ve
patients treated for chronic hepatitis B with
entecavir or entecavir plus tenofovir in the
BE-LOW study
F Zoulim1, G Carosi2, S Greenbloom3, W Mazur4,
T Nguyen5, L Jeffers6, M Brunetto7, M Lovegren8,
S Yu8, J Griffin9 and C Llamoso8 1INSERM U1052 and Lyon
University Hospital, France, 2University of Brescia, Italy, 3Toronto
Digestive Disease Associates Inc., Canada, 4Medical University of Silesia,
Poland, 5Alvarado Hospital, USA, 6University of Miami, USA,
7University Hospital Pisa, Italy, 8Bristol-Myers Squibb Company, USA,
9Bristol-Myers Squibb Company, France
PURPOSE OF STUDY: Entecavir (ETV) and tenofovir (TDF)
are potent antivirals for chronic hepatitis B (CHB) treatment.
Evolution of serum HBsAg levels may predict treatment response
in CHB. We examined the association between
changes in HBsAg levels and response to ETV+/-TDF in the
BE-LOW study.
METHODS: In this open-label, multicenter study, 379 nucleos(
t)ide-naı¨ve patients with HBeAg(+) or HBeAg(-) CHB
were randomized and treated with ETV 0.5 mg + TDF
300 mg (N = 197) or ETV 0.5 mg (N = 182) daily for
100 weeks. HBsAg levels were quantified (Abbott Architect
assay) at baseline and Weeks 12, 48 and 96.
RESULTS: Mean baseline HBsAg levels were comparable
across treatment arms (4.1 and 4.0 log10 IU/mL in ETV and
ETV+TDF arms, respectively), and across subgroups by
baseline ALT, genotype and age (<50 or ‡50 years old).
Mean changes in HBsAg level from baseline through Week
96 were similar in both treatment groups and in patients
with or without HBV DNA <50 IU/mL. Mean baseline
HBsAg level and mean change from baseline to Weeks 12,
48 and 96 were numerically higher in HBeAg(+) patients
compared with HBeAg(-) patients. In HBeAg(+) patients,
mean HBsAg decline was greater among those with HBeAg
loss vs those without.
CONCLUSIONS: In a mixed population of nucleos(t)ide-naı¨ve
CHB patients, decline in HBsAg levels through 96 weeks of
treatment was comparable between patients receiving ETV
and those receiving ETV + TDF. Greater declines in HBsAg
level were associated with HBeAg loss.
Fig. 1 Decline in HBsAG by treatment group and HBsAG
loss at week 96.
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